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Terminated

Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional applications

FDA Recall Z-1212-2012 · Posted 2012-03-29

Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeIZI
Date Initiated2011-11-19
Date Terminated2020-08-26
Product Quantity92 ( 24 Eleva 11s, and 68 Eleva FDs )

Reason for Recall

It was discovered there was a software error where the air karma rate is not displayed correctly on the user interface.

Firm Action

A field correction action will be undertaken to correct the software error in affected systems worldwide. Your proposed action to bring the product into compliance with regulatory requirements is to institute a worldwide field correction to replace the software error in affected systems by updating the current software to version R6.1.2. The timeframe for completion of this field action will be 6 months post field action publication. Preventive actions: The software has been corrected moving forward in subsequent releases for these products. For further questions please call (978) 787-1501.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA (nationwide)

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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